Comparison of Postoperative Quality of Recovery by Anesthetic Method in Patients Undergoing Shoulder Arthroscopy: Brachial Plexus Block for Pain Control Under General Anesthesia Versus Brachial Plexus Block for Surgical Block Under Sedation

Seoul National University Hospital1 site in 1 country140 target enrollmentOctober 30, 2024

ConditionsShoulder Arthroscopy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Shoulder Arthroscopy
Sponsor: Seoul National University Hospital
Enrollment: 140
Locations: 1
Primary Endpoint: Quality of recovery (QoR-15) at 48 hours post-surgery
Status: Recruiting
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of this study is to compare the quality of recovery in patients undergoing arthroscopic shoulder surgery depending on the type of anesthesia used:

general anesthesia with preoperative brachial plexus block for intra- and postoperative analgesia
regional anesthesia (brachial plexus block) with intraoperative sedation.

Registry

clinicaltrials.gov

Start Date

October 30, 2024

End Date

December 10, 2026

Last Updated

11 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Seoul National University Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients of age 19 years and above, scheduled for shoulder arthroscopic surgery

Exclusion Criteria

•emergency operation
•inflammation or infection at the site of nerve block administration
•inability to perform the quality of recovery questionnaire due to dementia or delirium
•severe lung disease (e.g. chronic obstructive pulmonary disease or interstitial lung disease)
•contraindication to brachial plexus block
•history of hypersensitivity or side effect to ropivacaine

Outcomes

Primary Outcomes

Quality of recovery (QoR-15) at 48 hours post-surgery

Time Frame: at 48 hours post-surgery

Quality of recovery (QoR-15) at 48 hours post-surgery (0-150)

Secondary Outcomes

Antiemetic administration(rom end of surgery up to 48 hours post-surgery)
Baseline hemidiagphramatic paralysis(On the day of surgery, before the operation)
Postoperative hemidiagphramatic paralysis(Immediately after surgery)
Quality of recovery (QoR-15) on the day before surgery(on the day before surgery)
Quality of recovery (QoR-15) 24 hours post-surgery(at 24 hours post-surgery)
Postoperative pain 1 hour post-surgery(at 1 hour post-surgery)
Postoperative pain 6 hours post-surgery(at 6 hours post-surgery)
Postoperative pain 12 hours post-surgery(at 12 hours post-surgery)
Postoperative pain 24 hours post-surgery(at 24 hours post-surgery)
Postoperative pain 48 hours post-surgery(at 48 hours post-surgery)
Incidence of postoperative nausea and/or vomiting (PONV) 1 hour post-surgery(at 1 hour post-surgery)
Incidence of postoperative nausea and/or vomiting (PONV) 6 hours post-surgery(at 6 hours post-surgery)
Incidence of postoperative nausea and/or vomiting (PONV) 12 hours post-surgery(at 12 hours post-surgery)
Incidence of postoperative nausea and/or vomiting (PONV) 24 hours post-surgery(at 24 hours post-surgery)
Incidence of postoperative nausea and/or vomiting (PONV) 48 hours post-surgery(at 48 hours post-surgery)
Rescue opioid analgesic administration(from end of surgery up to 48 hours post-surgery)